'Activity Pacing' in PLWH With Fatigue Symptoms.

Physical activity helps to improve health and prevent chronic diseases. However, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (CFCs), such as persons living with HIV (PLWH). We hypothesize that the "activity pacing", i.e. the strategy to optimize daily physical activity into manageable exercises in a way that should not exacerbate fatigue symptoms, may help a progressive improvement in physical activity of a group of PLWH with fatigue symptoms. Motivation and adherence to exercise will be monitored through the use of digital supports.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Infectious Diseases

Milan, 20127, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

of age ≥18 years;
either sedentary or already practicing mild/moderate physical activity (at least 150 minutes of moderate-intensity physical activity throughout the week);
able to sign the informed consent.

Exclusion criteria

The study will exclude HIV+ individuals:

with any HIV-related disease requiring hospitalization in the 6 weeks before enrolment;
with medical conditions (e.g. neurologic, muscular-skeletal, cardiovascular diseases) contraindicating non agonistic exercise, as established by a sport medicine specialist;
currently abusing of substance or alcohol;
already performing physical activity at higher level than the current WHO recommendations (30 minutes of moderate activity 5 times a week).

Treatment and study plan

Home-based physical activity

Behavioral

Participants will follow a personalized activity pacing program

Primary outcomes

Activity pacing improvement

Time frame: 16 week

To compare the improvement in the physical fitness between the Experimental Group and Control Group

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Registry information

Official study title

ActiPacMAN: 'Activity Pacing' in PLWH With Fatigue Symptoms. Monitoring Through the Combined Use of Actigraphy and Mobile App Notifications

Acronym: ActiPacMAN

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jan 18, 2022
Registry last updated: Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed